MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX60OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887360

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Edema (1820); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Weakness (2145); Heart Failure (2206); Discomfort (2330); Injury (2348); Respiratory Failure (2484); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 04/06/2016

Event Type  Death  

Manufacturer Narrative

(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Complaint description: patient email: (b)(6) is my husband and he received a depuy prosthesis on (b)(6) 2007 at (b)(6) medical center. Since last year he has suffered great pain and inability to walk and has been confined to bed due to a huge growth on his right thigh from metal from the prosthesis. This required three hospitalizations, two biopsies and one surgery to remove the growth and implant a temporary prosthesis. Now he needs a permanent prosthesis immediately which is made especially for him because the growth ate part of his pelvic bone and thigh muscle. His suffering and mine have been great. We are asking for (b)(6) to settle out of court and (b)(6) in court and an immediate payment to cover the cost of the prosthesis. Please, respond immediately and remember the suffering is intense. After loosening of prosthesis his wife asks us for compensation. Update (b)(6) 20 jun 2018: (b)(4) has been re-opened under (b)(4) due the litigation records received. Litigation alleges respiratory failure, pain, sleeping and walking difficulty, friction and wear between chromium and cobalt metal liner and head, toxic metal ions in blood, tissue, bone and elevated metal ions, resulting discomfort, hips weak, swelling, tense formation, weight loss, loss of mobility, loss range of motion, injury and mental anguish. On (b)(6) 2015 surgeon performed surgery to relieve pain and discomfort, found to have a tumor had formed and took it for biopsy. On (b)(6) 2015 second biopsy done. On (b)(6) 2016 explanted pinnacle and have it replaced temporary prosthesis implant. On (b)(6) 2016 another temporary prosthesis was implanted, permanent not done due to a serious infection. On (b)(6) 2016 permanent replacement was to be implanted, however, plaintiff condition deteriorated, necessitating hospice care. On (b)(6) 2016 patient died due to acute cardiovascular and respiratory insufficiency as a direct result of complications from multiple surgeries. Added law firm name, lawyer name. Updated dor and patient harm of the ip's. Doi: (b)(6) 2007; dor: (b)(6) 2016; right hip.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Udi: (b)(4). Corrected: middle initial.

Manufacturer Narrative

Product complaint # (b)(4). Investigation summary: no device associated with this report was received for examination. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Udi: (b)(4).

Event Description

Update ad 11 sep 2018: corrected patient code for swelling and metallosis.

Manufacturer Narrative

Product complaint # (b)(4). Investigation summary: no device associated with this report was received for examination. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: PINNACLE MTL INS NEUT36IDX60OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6103142063
• MDR Report Key: 7689612
• MDR Text Key: 114030863
• Report Number: 1818910-2018-64453
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 12/31/2011
• Device Catalogue Number: 121887360
• Device Lot Number: 2279080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/16/2018 Patient Sequence Number: 1